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NCT01921335 · ClinicalTrials.gov registry record · Phase 1
ARRY-380 + Trastuzuamab for Breast w/ Brain Mets
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01921335: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01921335 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921335, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of different doses of ARRY-380 in combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested. Both agents block the HER2 receptor, which is thought to be overactive in HER2-positive breast cancer. It is thought that ARRY-380 and trastuzumab might work together because they attach to different parts of the HER2 receptor and prevent it from functioning. Because HER2 positive breast cancer contains high levels of HER2 receptor, but normal cells in your body generally do not, the drugs may be able to "target" the cancer cells. In addition, in laboratory studies, ARRY-380 appears to have some penetration into the brain.
Primary Outcome
To determine the maximum-tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ARRY-380 in combination with trastuzumab in participants with HER2+ breast cancer and central nervous system (CNS metastasis)
Interventions
- DRUG Trastuzumab
- DRUG ARRY-380 Twice Daily Dosage
- DRUG ARRY-380 Once Daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-08 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
What the finished NCT01921335 record still lists
NCT01921335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01921335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01921335 about?
NCT01921335 is a clinical study titled "ARRY-380 + Trastuzuamab for Breast w/ Brain Mets". The purpose of this study is to test the safety of different doses of ARRY-380 in combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested. Both agents block the ...
What is the current status of trial NCT01921335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-08. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT01921335?
The interventions under investigation include: Trastuzumab (DRUG), ARRY-380 Twice Daily Dosage (DRUG), ARRY-380 Once Daily (DRUG).
Who is sponsoring clinical trial NCT01921335?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921335's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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